Many clinicians and researchers believe that patients who expect that a specific treatment will relieve their symptoms will be more likely to benefit from that treatment. However, analyses of data from clinical trials evaluating complementary and alternative medicine (CAM) treatments for chronic back pain have not consistently found pre-treatment expectations to be predictive of superior outcomes. Interpretation of these conflicting results has been complicated by the absence of an adequate conceptual model of how patient expectations might affect treatment outcomes and the lack of a validated questionnaire for capturing patient expectations. To help advance understanding of the relationship between expectations and treatment outcomes, this application proposes to systematically develop and validate a questionnaire to assess patient expectations of CAM therapies for chronic back pain. Phase I of this 3-phase project will focus on gaining a comprehensive understanding of the issues underlying the concept of treatment expectations. This will involve conducting interviews to collect qualitative information about expectations from patients with back pain as well as from providers of four CAM therapies commonly used for back pain (acupuncture, chiropractic, massage, yoga). Rigorous qualitative research methods will be used to analyze this interview data in order to identify key conceptual domains associated with the development of expectations. The results of these analyses will then be used to create a conceptual model about how patient expectations of treatment success develop and change after initiation of treatment. Phase II activities will focus on developing a questionnaire to assess patient expectations and Phase III will feature testing the psychometric properties of the questionnaire (e.g., reliability and validity). The questionnaire will be tested in diverse clinical and research populations. This project is expected to result in the creation of a psychometrically sound questionnaire that can be used by the CAM and conventional research communities to measure the importance of patient expectations of treatment outcomes in clinical trials of non-pharmacologic treatments for chronic back pain. Development of a conceptual model for understanding the relationship between patient expectations and treatment outcomes and creation of a valid and reliable questionnaire for assessing patient expectations will provide valuable tools for future research on how context effects influence treatment outcomes. Such research has the potential to improve understanding of how to most effectively translate the results of randomized efficacy trials into clinical practice.